AFFINITY BLOOD PUMP SYSTEM— 510(k) K964017

Name: FDA 510(k) clearance K964017
Creator: U.S. Food and Drug Administration
Published: 1997-08-05

Substantially Equivalent

Avecor Cardiovascular, Inc.

FDA 510(k) clearance K964017 for AFFINITY BLOOD PUMP SYSTEM, Substantially Equivalent on 1997-08-05. Applicant: Avecor Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Avecor Cardiovascular, Inc.
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 1996-10-07
Decision date: 1997-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Avecor Cardiovascular, Inc.

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K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE1998-02-18
K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM1997-07-11
K952532 — AFFINITY ARTERIAL BLOOD FILTER1995-10-06
K940126 — AVECOR PRE-BYPASS FILTER1994-06-28
K936003 — AFFINITY CVR1994-06-20

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.